← Human Trials & Peer-Reviewed Studies
Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
Plain-language guide to NCT01511198: phase 2 randomized trial of Liraglutide, 223 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01511198
- Phase
- phase 2
- Status
- completed
- Start
- 2001-02
- Completion (planned or actual)
- 2001-10
- Participants
- 223 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Liraglutide.
This trial is conducted in the United States of America (USA).
It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 223 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetic. Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed. Body Mass Index (BMI) between 27.0-42.0 kg/m\^2 (inclusive).
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: cardiac problems; uncontrolled treated/untreated hypertension; proliferative retinopathy or known autonomic neuropathy.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
The Liraglutide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.
Those kept unaware of assignments: participant and investigator.
It started in 2001-02 with completion listed for 2001-10.
It ran at 39 sites in United States (39).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Body weight.
It also tracked 5 secondary outcomes, for example FPG (fasting plasma glucose), HbA1c (glycosylated haemoglobin), Fructosamine, Lipids and Adverse events.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Liraglutide in 223 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.